MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT; SHARPS CONTAINER

Catalog Number 300195

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one sharps coll asia 13.2l yel 1508 non-vent has been found with a broken lid before use.The following has been provided by the initial reporter: broken sharp cover.We received feedback on the quality issue on the 13.2l sharp container.Users detected that lid for the sharp container has broken, it will cause potential harm to users as well as to the public since the lid cannot be locked.Item details: material code: 1306-01-009-a.Material description: container contaminated sharp 13.2l.Product code: 300195.Batch no.: 8274903.Affected quantity: 1 pc.

Event Description

It has been reported that one sharps coll asia 13.2l yel 1508 non-vent has been found with a broken lid before use.The following has been provided by the initial reporter: broken sharp cover we received feedback on the quality issue on the 13.2l sharp container.Users detected that lid for the sharp container has broken, it will cause potential harm to users as well as to the public since the lid cannot be locked item details: material code: 1306-01-009-a, material description: container contaminated sharp 13.2l, product code: 300195, batch no.8274903, affected quantity: 1 pc.

Manufacturer Narrative

H.6.Investigation: a sample picture was provided for the issue and a compliant review was performed by the manufacturer.An investigation was completed for the issue of lid broken and cannot be locked.A dhr review and nonconformance review showed there were no issues observed for lid broken.Based on the sample the cap of the lid was detached from the hinge, there are stress marks at both sides of the hinge, and the rupture of the hinge was not uniform.According with this investigation the failure mode appears to be caused by a molding issue during the manufacturing process.The process mold will be updated to provide greater hinge support to avoid breaking.H3 other text : see h.10.

• Brand Name: SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9364942
• MDR Text Key: 175253091
• Report Number: 2243072-2019-02643
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300195
• Device Lot Number: 8274903
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other